OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indic
FDA device recall Z-1515-2015 · posted 2015-04-23 · Terminated
Recall details
- Recalling firm
- Abbott Medical Optics, Inc.
- Reason for recall
- Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
- Action taken
- Abbott Medical Optics (AMO) sent an Advisory Notice letter dated March 5, 2015 via FedEx overnight delivery to each Catalys Precision Laser System owner. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the attached Acknowledgement Form. For questions contact AMO Technical Support at 1-855-662-0911.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OOE
- Quantity affected
- 202
- Distribution
- Worldwide Distribution - US Nationwide and the countries of, Canada, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Thailand
- Date initiated
- 2015-02-20
- Date posted
- 2015-04-23
- Date terminated
- 2019-07-09
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIMEDICA CATALYS PRECISION LASER SYSTEM (K141079) | Optimedica Corporation | 2014-09-11 |